Bright Light Treatment At Home To Improve Symptom Management of Fibromyalgia Syndrome

在家进行强光治疗可改善纤维肌痛综合征的症状管理

基本信息

批准号：
9794137
负责人：
Helen Julia Burgess
金额：
$ 18.78万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-26 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9794137
关键词：
Address Affect Aftercare American Amygdaloid structure Analgesics Antidepressive Agents Antiepileptic Agents Anxiety Applications Grants Behavior Therapy Chronic Disease Cognitive Therapy Comorbidity Data Development Devices Distress Dropout Etiology Exercise Exploratory/Developmental Grant Fatigue Fibromyalgia Foundations Functional disorder Home environment Human Resources Impaired cognition Individual Interdisciplinary Study Internet Intervention Lead Light Link Measures Mediator of activation protein Medical Melatonin Obstructive Sleep Apnea Pain Pain Clinics Pain intensity Patients Persons Pharmaceutical Preparations Pharmacology Phase Phototherapy Pilot Projects Placebos Productivity Proxy Public Health Quality of life Randomized Reporting Research Project Grants Risk Risk Factors Sample Size Services Severities Sleep Sleep Apnea Syndromes Sleep disturbances Source Strategic Planning Symptoms Testing Time Unemployment alternative treatment base chronic pain chronic widespread pain circadian circadian pacemaker compliance behavior cost effective depressive symptoms disability disturbance in affect effective therapy fibromyalgia pain improved improved functioning innovation modifiable risk negative affect novel optimal treatments pain catastrophizing pain reduction pain sensitivity reduce symptoms sex side effect sleep quality symptom management symptomatic improvement treatment effect treatment group treatment strategy

项目摘要

ABSTRACT Fibromyalgia syndrome (FMS) is characterized by chronic widespread pain, affect/sleep disturbance, fatigue, and cognitive dysfunction. People with FMS report high distress, disability, lost productivity, and poor quality of life. FMS is estimated to affect over 6.5 million Americans and thus represents an important public health problem. A range of pharmacological agents have been tested (antidepressants, antiepileptic medications), but findings indicate only small effects with a high rate of dropout due to adverse side-effects. Cognitive behavioral therapy (CBT) and exercise have also been tested, but have only small to modest effects. Thus, there is an urgent need to develop readily available, affordable, safe, and practical adjunctive approaches to manage FMS symptoms. In this R21 Exploratory/Developmental research grant, we will examine the extent to which a morning light treatment improves function, pain intensity, and pain sensitivity in people with FMS (n=60). We will assess baseline function, pain intensity, and pain sensitivity. Subjects will then be randomized (stratified 18-29 years vs. older): to one of two treatments: 4 weeks of bright morning light (1 h/day) or 4 weeks of dim (placebo) morning light (1 h/day). Subjects will have reassessments of function, pain intensity, and pain sensitivity at mid-treatment and post-treatment. Our pilot data suggests that morning bright light treatment can meaningfully reduce FMS symptoms. In the proposed study, we will reduce subject burden and increase innovation by testing a wearable light device (bright vs. dim Re-timer®) with objective measures of treatment compliance. Aim 1 is to determine the effect of bright versus dim (placebo) morning light treatment on function, pain intensity, and pain sensitivity in individuals with FMS. We hypothesize that function, pain intensity, and pain sensitivity will improve significantly more in the bright light treatment group than in the dim (placebo) light treatment group. Aim 2 is to determine the effect of bright vs. dim (placebo) morning light treatment on potential treatment mediators: morningness-eveningness (a proxy measure of circadian timing), sleep, negative affect, pain catastrophizing, and analgesic medication use. We hypothesize that these variables will significantly improve more with bright light than dim light treatment, and changes in these potential mediators will be associated with changes in function, pain intensity, and pain sensitivity. The Exploratory Aim is to explore whether obstructive sleep apnea severity and/or subject sex moderate treatment effects. The results will provide a foundation for a well-powered R01 RCT to test if morning light (bright vs. placebo), as a non- pharmacological adjunctive treatment, can enhance existing treatments for FMS (e.g. CBT, internet-based CBT, exercise) to improve symptom management. This R21 grant application answers PA-16-008, which calls for “interdisciplinary research to decrease symptom burden in persons with chronic illness through developing and testing innovative, cost-effective, targeted interventions” and also addresses NINR's strategic plan calling for “better symptom management of chronic pain and innovative behavioral treatments applied at home”.

抽象的纤维肌痛综合征 (FMS) 的特点是慢性广泛疼痛、情感/睡眠障碍、疲劳、患有 FMS 的人表现出高度的痛苦、残疾、生产力下降和生活质量差。据估计，FMS 影响着超过 650 万美国人，因此代表着重要的公共卫生问题。已经测试了一系列药物（抗抑郁药、抗癫痫药物），但是研究结果表明，由于不良认知行为副作用，影响很小，但退出率很高。疗法（CBT）和运动也已被测试过，但效果很小到中等。迫切需要开发现成的、负担得起的、安全且实用的辅助方法来管理 FMS 在这项 R21 探索性/发展性研究资助中，我们将研究症状的程度。晨光治疗可改善 FMS 患者的功能、疼痛强度和疼痛敏感性 (n=60)。将评估基线功能、疼痛强度和疼痛敏感性，然后将受试者随机化（分层）。 18-29 岁与以上）：两种治疗之一：4 周明亮晨光（每天 1 小时）或 4 周昏暗晨光（安慰剂）晨光（1 小时/天）受试者将重新评估功能、疼痛强度和疼痛。我们的试验数据表明，早晨强光治疗可以提高治疗期间和治疗后的敏感性。有意义地减少FMS症状在拟议的研究中，我们将减轻受试者的负担并增加。通过使用客观的治疗措施测试可穿戴光设备（明亮与昏暗的 Re-timer®）进行创新目标 1 是确定明亮与昏暗（安慰剂）晨光治疗对功能的影响。我们对 FMS 患者的疼痛强度和疼痛敏感性进行了研究。与暗光（安慰剂）光治疗组相比，亮光治疗组的疼痛敏感性显着改善目标 2 是确定明亮与昏暗（安慰剂）晨光治疗对治疗组的影响。潜在的治疗中介：早晚（昼夜节律计时的替代指标）、睡眠、我们发现这些变量会产生负面影响、灾难性疼痛和镇痛药物的使用。强光治疗比弱光治疗有显着改善，并且这些潜在介质的变化与功能、疼痛强度和疼痛敏感性的变化相关。探索的目的是探讨阻塞性睡眠呼吸暂停的严重程度和/或受试者性别是否会影响治疗效果。将为功能强大的 R01 RCT 提供基础，以测试晨光（明亮与安慰剂）是否作为非药物辅助治疗，可以增强现有的 FMS 治疗（例如 CBT、基于互联网的治疗） CBT、锻炼）以改善症状管理。此 R21 拨款申请回答了 PA-16-008，该申请呼吁。表彰“通过开展跨学科研究来减轻慢性病患者的症状负担” 和创新的、具有成本效益的、有针对性的干预措施”，并解决了 NINR 的战略计划呼吁表彰“更好的慢性疼痛症状管理和在家应用的创新行为治疗”。